In the latest part of its “beyond our borders” scheme, the US FDA is asking drugmakers to volunteer supply chain information for drugs and APIs sourced outside the USA.
The pilot plan, whose launch coincides with today’s opening safety offices in India, will assess the importation practices of 100 applicant drugmakers to determine the feasibility of setting up a supply chain monitoring network.
At present, more than 80 per cent of the active pharmaceutical ingredients (API) sold in the US are sourced from overseas according to government statistics, with the majority coming from manufacturers in India and China.
Michael Chappell, the Food and Drug Administration’s (FDA) acting associate commissioner of regulatory affairs, explained that: “It is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don’t meet the FDA’s standards and violate US laws.”
Deborah Autor, director of the office of compliance in FDA’s Center for Drug Evaluation and Research (CDER) agreed, commenting that: “This initiative creates incentives for drug makers to develop and maintain secure supply chains,” stressing that “this is one of several agency initiatives to enhance drug product safety.”
Drugmakers wishing to participate in the two-year scheme must meet certain requirements, with the main criteria being an ability to demonstrate complete supply chain security from source to final destination in the US.